FIELD OF THE INVENTION
[0001] The present invention relates to devices and methods for adjusting the height of
devices in a gastric restriction system.
BACKGROUND OF THE INVENTION
[0002] Obesity is becoming a growing concern, particularly in the United States, as the
number of obese people continues to increase and more is learned about the negative
health effects of obesity. Morbid obesity, in which a person is 100 pounds or more
over ideal body weight, in particular poses significant risks for severe health problems.
Accordingly, a great deal of attention is being focused on treating obese patients.
One method of treating morbid obesity has been to place a restriction device, such
as an elongated band, about the upper portion of the stomach. Gastric bands have typically
comprised a fluid-filled elastomeric balloon with fixed endpoints that encircles the
stomach just inferior to the esophageal-gastric junction to form a small gastric pouch
above the band and a reduced stoma opening in the stomach. When fluid is infused into
the balloon, the band expands against the stomach creating a food intake restriction
or stoma in the stomach. To decrease this restriction, fluid is removed from the band.
The effect of the band is to reduce the available stomach volume and thus the amount
of food that can be consumed before becoming "full."
[0003] Food restriction devices have also comprised mechanically adjusted bands that similarly
encircle the upper portion of the stomach. These bands include any number of resilient
materials or gearing devices, as well as drive members, for adjusting the bands. Additionally,
gastric bands have been developed that include both hydraulic and mechanical drive
elements. An example of such an adjustable gastric band is disclosed in
U.S. Pat. No. 6,067,991, entitled "Mechanical Food Intake Restriction Device" which issued on May 30, 2000,
and is incorporated herein by reference. It is also known to restrict the available
food volume in the stomach cavity by implanting an inflatable elastomeric balloon
within the stomach cavity itself. The balloon is filled with a fluid to expand against
the stomach walls and, thereby, decrease the available food volume within the stomach.
[0004] With each of the above-described food restriction devices, safe, effective treatment
requires that the device be regularly monitored and adjusted to vary the degree of
restriction applied to the stomach. With banding devices, the gastric pouch above
the band will substantially increase in size following the initial implantation. Accordingly,
the stoma opening in the stomach must initially be made large enough to enable the
patient to receive adequate nutrition while the stomach adapts to the banding device.
As the gastric pouch increases in size, the band may be adjusted to vary the stoma
size. In addition, it is desirable to vary the stoma size in order to accommodate
changes in the patient's body or treatment regime, or in a more urgent case, to relieve
an obstruction or severe esophageal dilatation. Traditionally, adjusting a hydraulic
gastric band required a scheduled clinician visit during which a hypodermic needle
and syringe were used to permeate the patient's skin and add or remove fluid from
the balloon. More recently, implantable pumps have been developed which enable non-invasive
adjustments of the band. An external programmer communicates with the implanted pump
using telemetry to control the pump. During a scheduled visit, a physician places
a hand-held portion of the programmer near the gastric implant and transmits power
and command signals to the implant. The implant in turn adjusts the fluid levels in
the band and transmits a response command to the programmer.
[0005] During these gastric band adjustments, it has been difficult to determine how the
adjustment is proceeding, and whether the adjustment will have the intended effect.
In an attempt to determine the efficacy of an adjustment, some physicians have utilized
fluoroscopy with a Barium swallow as the adjustment is being performed. However, fluoroscopy
is both expensive and undesirable due to the radiation doses incurred by both the
physician and patient. Other physicians have instructed the patient to drink a glass
of water during or after the adjustment to determine whether the water can pass through
the adjusted stoma. This method, however, only assures that the patient is not obstructing,
and does not provide any information about the efficacy of the adjustment. Oftentimes,
a physician may simply adopt a "try as you go" method based upon their prior experience,
and the results of an adjustment may not be discovered until hours or days later,
when the patient experiences a complete obstruction of the stomach cavity, or the
band induces erosion of the stomach tissue.
[0006] Additionally, a gastric band adjustment can be complicated by difficult accessibility
of implanted gastric band elements. Gastric band elements are typically initially
secured beneath layers of fat tissue that can make the elements difficult to locate.
As the patient loses weight, the elements can shift within the body, causing patient
discomfort and/or making the elements harder for a physician to locate and access.
[0007] Accordingly, methods and devices are provided for use with a gastric restriction
device, and in particular for accessing gastric restriction elements.
SUMMARY OF THE INVENTION
[0008] The present invention generally provides methods and devices for adjusting the height
of devices in a gastric restriction system. In one embodiment, a restriction system
for forming a restriction in a patient is provided that includes an implantable restriction
device that can form a restriction in a patient. The system also includes an implantable
housing coupled to the implantable restriction device and having an adjustable height.
The housing can be in fluid communication with the implantable restriction device
and include, for example, a fill port that can receive fluid from a fluid source external
to the patient for delivering fluid to the implantable restriction device. In other
embodiments, the housing can include a pressure sensor that can sense a pressure of
fluid within the implantable restriction device and communicate pressure data to an
external monitor. The housing can be at least partially formed from a bioabsorbable
material (e.g., polylactide, polyglycolide, poly(lactide co glycolide), polyanhydride,
and polyorthoester) operable to adjust the height of the housing over time.
[0009] The system can also include a coupling element extending between a base of the housing
and a body of the housing. The coupling element can alter a distance between the base
and the body to thereby adjust the height of the housing. The coupling element can
be movable between at least two successive positions in which the housing has a height
that lowers with each successive position of the coupling element.
[0010] The coupling element can have a variety of configurations, such as a collapsible
structure, a retractable cord, and a fluid filled chamber in which a change of fluid
volume within the chamber can alter the distance between the base and the body. Another
coupling element configuration includes a depressible element, e.g., a button formed
on one of the housing's body and base, that can be depressed to move the coupling
element between at least two successive positions. In other embodiments, the coupling
element includes at least one flexible tab extending between the base and the body
that can maintain the housing in one or more successive positions. In some embodiments,
the coupling element includes a compliant mechanism (e.g., a spring) compressible
to decrease the distance between the base and the body. The coupling element can further
include a rack that is coupled to the compliant mechanism and that includes a plurality
of teeth. A pawl can engage the rack for maintaining the housing at a selected height.
[0011] In another embodiment, a restriction system for forming a restriction in a patient
includes an implantable restriction device that can form a restriction in a patient
and an implantable housing coupled to the implantable restriction device. The housing
has a body and a base that are movably coupled to one another to allow a height of
the housing to be adjusted. The base can be formed from a bioabsorbable material that
can adjust the height of the housing over time. In some embodiments, the system also
includes a coupling element extending between the base and the body that can alter
a distance between the base and the body to thereby adjust the height of the housing.
The coupling element can be movable between at least two successive positions in which
the housing has a height that lowers with each successive position of the coupling
element.
[0012] In other aspects, a method of forming a restriction in a patient is provided. The
method includes implanting a restriction device in a patient to form a restriction
and adjusting a height of a housing coupled to the restriction device and implanted
within tissue to lower a profile of the housing. Adjusting a height of the housing
can include adjusting a coupling element extending between a base of the housing and
a body of the housing. In other embodiments, adjusting a height of the housing includes
allowing the housing to biomedically degrade within the patient.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] The invention will be more fully understood from the following detailed description
taken in conjunction with the accompanying drawings, in which:
[0014] FIG. 1A is a schematic diagram of an embodiment of a food intake restriction system;
[0015] FIG. 1B is a perspective view of an embodiment of an implantable portion of the food
intake restriction system of FIG. 1;
[0016] FIG. 2A is a perspective view of the food intake restriction device of FIG. 1;
[0017] FIG. 2B is a schematic diagram of the food intake restriction device of FIG. 2A applied
about the gastro esophageal junction of a patient;
[0018] FIG. 3 is a perspective view of an embodiment of the injection port housing of FIG.
1;
[0019] FIG. 4 is a perspective view of an embodiment of the sensor housing of FIG. 1;
[0020] FIG. 5 is a cross sectional schematic view of an embodiment of an implantable port
housing having fluid disposed in an internal cavity of the housing;
[0021] FIG. 6 is a cross sectional schematic view of an embodiment of an implantable sensor
housing having fluid disposed in an internal cavity of the housing;
[0022] FIG. 7 is a cross sectional schematic view of an embodiment of an implantable housing
having a spring disposed in an internal cavity of the housing;
[0023] FIG. 8 is a cross sectional schematic view of an embodiment of an implantable housing
having a flexible tab disposed in an internal cavity of the housing;
[0024] FIG. 9 is a cross sectional schematic view of an embodiment of an implantable housing
having a depressible element;
[0025] FIG. 10 is a cross sectional schematic view of an embodiment of an implantable housing
at least partially formed from a bioabsorbable material;
[0026] FIG. 11 is a schematic view of an embodiment of an implantable housing having a collapsible
structure, shown in an expanded position;
[0027] FIG. 12 is a schematic view of the implantable housing of FIG. 11 showing the collapsible
structure in a collapsed position;
[0028] FIG. 13 is a schematic view of another embodiment of an implantable housing having
a collapsible structure, shown in an expanded position;
[0029] FIG. 14 is a schematic view of the implantable housing of FIG. 13 showing the collapsible
structure in a collapsed position;
[0030] FIG. 15 is a schematic view of an embodiment of an implantable housing having a rack
that can be engaged by a pawl; and
[0031] FIG. 16 is a schematic view of an embodiment of an implantable housing having a retractable
cord.
DETAILED DESCRIPTION OF THE INVENTION
[0032] Certain exemplary embodiments will now be described to provide an overall understanding
of the principles of the structure, function, manufacture, and use of the devices
and methods disclosed herein. One or more examples of these embodiments are illustrated
in the accompanying drawings. Those skilled in the art will understand that the devices
and methods specifically described herein and illustrated in the accompanying drawings
are non limiting exemplary embodiments and that the scope of the present invention
is defined solely by the claims. The features illustrated or described in connection
with one exemplary embodiment may be combined with the features of other embodiments.
Such modifications and variations are intended to be included within the scope of
the present invention.
[0033] The present invention generally provides devices and methods for adjusting the height
of devices in a gastric restriction system. In general, the devices and methods allow
one or more implantable housings coupled to an implantable restriction device to have
an adjustable height. The housing can include, for example, a fill port housing, a
sensor housing, and any other type of housing that can be used in an implantable restriction
system and desired to have an adjustable height. The housing can lower in profile
over time, e.g., as the patient loses weight, thereby maintaining the housing in a
generally predictable location where it can be found and accessed. The profile can
automatically adjust internal to the patient, thereby reducing or eliminating the
need for invasive, expensive, time consuming, or risky procedures involving adjustment
of the gastric restriction system. The housing can instead or in addition be manually
adjusted in height from outside the patient to, for example, relieve patient discomfort.
Furthermore, the housing can include a base that secures the housing to the patient's
fascia and a body that includes the functionality of the housing near the patient's
skin surface. The housing's base and body can be separated by a distance and connected
by a coupling element that can operate to alter the distance between the body and
the base. In this way, the housing body can maintain its generally predictable location
while the housing lowers in profile over time.
[0034] While the present invention can be used with a variety of restriction systems known
in the art, FIG. 1A illustrates one exemplary embodiment of a food intake restriction
system 10 in use in a patient. As shown, the system 10 generally includes an implantable
portion 10a and an external portion 10b. FIG. 1B illustrates the implantable portion
10a outside of a patient. The implantable portion 10a includes an adjustable gastric
band 20 that is configured to be positioned around the upper portion of a patient's
stomach 40, and an injection port housing 30 that is fluidly coupled to the adjustable
gastric band 20, e.g., via a catheter 50.
[0035] The injection port housing 30 can include a port body 30a and a port base 30b that
are coupled together, although the port body 30a and the port base 30b can be separated
by a distance. The injection port housing 30, through the port body 30a, is adapted
to allow fluid to be introduced into and removed from the gastric band 20 to thereby
adjust the size of the band and thus the pressure applied to the stomach. The injection
port housing 30 is adapted to be fixed to the patient at the port base 30b, which
can be implanted at a location within the body that allows the port body 30a to be
accessible through the tissue. Typically, injection port housings are fixated to the
patient in the lateral subcostal region of the patient's abdomen under the skin and
layers of fatty tissue. Surgeons also typically fix injection port housings on the
sternum of the patient. Wherever implanted, the injection port housing 30 can be adjusted
in height as described further below.
[0036] The internal portion 10a can also include a pressure sensing or measuring device
in fluid communication with the closed fluid circuit in the implantable portion 10a
such that the pressure measuring device can measure the fluid pressure of the closed
fluid circuit. While the pressure measuring device can have various configurations
and it can be positioned anywhere along the internal portion 10a, including within
the injection port housing 30, in the illustrated embodiment the pressure measuring
device is in the form of a pressure sensor that is disposed within a sensor housing
60 positioned adjacent to the injection port housing 30. More specifically, the pressure
sensor in this embodiment can be disposed in a sensor body 60a of the sensor housing
60, which also includes a sensor base 60b that can be fixed to the patient and be
coupled to the sensor body 60a. The catheter 50 can include a first portion that is
coupled between the gastric band 20 and the pressure sensor housing 60, and a second
portion that is coupled between the pressure sensor housing 60 and the injection port
housing 30. Although in this embodiment both the port housing 30 and the sensor housing
60 are shown having body and base portions, in some embodiments, only one of the housings
in the implantable portion 10a (the port housing 30, the sensor housing 60, or another
housing) may have such a base and body to adjust the housing's height.
[0037] As further shown in FIG. 1A, the external portion 10b generally includes a pressure
reading device 70 that is configured to be positioned on the skin surface above the
pressure sensor housing 60 (which can be fixed to the patient beneath thick tissue,
e.g., over 10 cm thick) to non invasively communicate with the pressure measuring
device and thereby obtain pressure measurements. The pressure reading device 70 can
optionally be electrically coupled (in this embodiment via an electrical cable assembly
80) to a control box 90 that can display the pressure measurements, or other data
obtained from the pressure reading device 70.
[0038] FIG. 2A shows the gastric band 20 in more detail. While the gastric band 20 can have
a variety of configurations, and various gastric bands currently known in the art
can be used with the present invention, in the illustrated embodiment the gastric
band 20 has a generally elongate shape with a support structure 22 having first and
second opposite ends 20a, 20b that can be secured to each other. Various mating techniques
can be used to secure the ends 20a, 20b to one another. In the illustrated embodiment,
the ends 20a, 20b are in the form of straps that mate together, with one laying on
top of the other. In another embodiment, illustrated in FIG. 1B, a support structure
at one end of the gastric band 20 can include an opening through which the other end
of the gastric band 20 can feed through to secure the ends to one another. The gastric
band 20 can also includes a variable volume member, such as an inflatable balloon
24, that is disposed or formed on one side of the support structure 22 and that is
configured to be positioned adjacent to tissue. The balloon 24 can expand or contract
against the outer wall of the stomach to form an adjustable stoma for controllably
restricting food intake into the stomach.
[0039] A person skilled in the art will appreciate that the gastric band can have a variety
of other configurations. Moreover, the various methods and devices disclosed herein
have equal applicability to other types of implantable bands. For example, bands are
used for the treatment of fecal incontinence, as described in
U.S. Pat. No. 6,461,292 which is hereby incorporated herein by reference. Bands can also be used to treat
urinary incontinence, as described in
U.S. Patent Application 2003/0105385 which is hereby incorporated herein by reference. Bands can also be used to treat
heartburn and/or acid reflux, as disclosed in
U.S. Pat. No. 6,470,892 which is hereby incorporated herein by reference. Bands can also be used to treat
impotence, as described in
U.S. Patent Application 2003/0114729 which is hereby incorporated herein by reference.
[0040] FIG. 2B shows the adjustable gastric band 20 applied about the gastro esophageal
junction of a patient. As shown, the band 20 at least substantially encloses the upper
portion of the stomach 40 near the junction with the esophagus 42. After the band
20 is implanted, preferably in the deflated configuration wherein the band 20 contains
little or no fluid, the band 20 can be inflated, e.g., using saline, to decrease the
size of the stoma opening. A person skilled in the art will appreciate that various
techniques, including mechanical and electrical techniques, can be used to adjust
the band.
[0041] The fluid injection port housing 30 can also have a variety of configurations. In
the embodiment shown in FIG. 3, the port body 30a and the port base 30b of the injection
port housing 30 each have a generally cylindrical shape. The port body 30a can at
least partially surround the port base 30b, as shown. Additionally, the port body
30a and the port base 30b are shown compressed together in FIG. 3, but the port body
30a and the port base 30b can be separated by a distance. The port body 30a can couple
with the port base 30b in a variety of ways, described further below, that generally
allow the housing 30 to have an adjustable height such that the port body 30a can
maintain proximity to a surface of the patient's skin while the port base 30b fixes
the port housing 30 to the patient at a location that can be, and typically is initially
following implantation of the housing 30, remote from the port body 30a.
[0042] The port body 30a has a distal or bottom surface and a perimeter wall extending proximally
from the bottom surface and defining a proximal opening 32. The proximal opening 32
can include a needle penetrable septum 34 extending there across and providing access
to a fluid reservoir (not visible in FIG. 3) formed within the port body 30a. The
septum 34 is preferably placed in a proximal enough position such that the depth of
the reservoir is sufficient enough to expose the open tip of a needle, such as a Huber
needle, so that fluid transfer can take place. The septum 34 is preferably arranged
so that it will self seal after being punctured by a needle and the needle is withdrawn.
[0043] As further shown in FIG. 3, the port housing 30 can further include a catheter tube
connection member 36 that is in fluid communication with the reservoir and that is
configured to couple to the catheter 50. A person skilled in the art will appreciate
that the housing 30 can be made from any number of materials, including stainless
steel, titanium, or polymeric materials, and the septum 34 can likewise be made from
any number of materials, including silicone.
[0044] As indicated above, the system 10 can also include a pressure measuring device 64,
as shown in FIG. 4, that is in communication with the closed fluid circuit and that
is configured to measure the fluid pressure, which corresponds to the amount of restriction
applied by the adjustable gastric band 10 to the patient's stomach 40. Measuring the
fluid pressure enables a physician to evaluate the restriction created by a band adjustment.
In the illustrated embodiment, the pressure measuring device 64 is in the form of
a pressure sensor that is disposed within the sensor body 60a of the sensor housing
60. The pressure measuring device 64 can, however, be disposed anywhere within the
closed hydraulic circuit of the implantable portion 10a, and various exemplary locations
and configurations are disclosed in more detail in commonly-owned
U.S. Publication No. 2006/0211913 entitled "Non-Invasive Pressure Measurement In a Fluid Adjustable Restrictive Device,"
filed on March 7, 2006, and hereby incorporated by reference in its entirety.
[0045] In general, the illustrated sensor housing 60 includes an inlet 62a and an outlet
62b, both typically part of the sensor body 60a, that are in fluid communication with
the fluid in the system 10. A sensor 64 is disposed within the sensor housing 60 and
is configured to respond to fluid pressure changes within the hydraulic circuit and
convert the pressure changes into a usable form of data. While not shown, the pressure
sensing system can also include a microcontroller, a TET/telemetry coil, and a capacitor.
Optionally, the pressure sensing system can further comprise a temperature sensor
(not shown). The microcontroller, the TET/telemetry coil, and the capacitor can be
in communication via a circuit board (not shown) or any via any other suitable component(s).
It will also be appreciated that the TET/telemetry coil and the capacitor may collectively
form a tuned tank circuit for receiving power from external portion, and transmitting
the pressure measurement to the pressure reading device 70.
[0046] Various pressure sensors known in the art can be used, such as a wireless pressure
sensor provided by CardioMEMS, Inc. of Atlanta, Georgia, though a suitable MEMS pressure
sensor may be obtained from any other source, including but not limited to Integrated
Sensing Systems, Inc. (ISSYS) of Ypsilanti, Michigan, and Remon Medical Technologies,
Inc. of Waltham, Massachusetts. One exemplary MEMS pressure sensor is described in
U.S. Patent No. 6,855,115, the disclosure of which is incorporated by reference herein for illustrative purposes
only. It will also be appreciated that suitable pressure sensors may include, but
are not limited to, capacitive, piezoresistive, silicon strain gauge, or ultrasonic
(acoustic) pressure sensors, as well as various other devices capable of measuring
pressure.
[0047] The pressure reading device 70 can also have a variety of configurations, and one
exemplary pressure reading device is disclosed in more detail in commonly-owned
U.S. Publication No. 2006/0189888 and
U.S. Publication No. 2006/0199997, which are hereby incorporated by reference in its entirety. In general, the pressure
reading device 70 can non-invasively measure the pressure of the fluid within implanted
portion even when the injection port housing 30 or the pressure measuring device 64
is implanted beneath thick (at least over 10 cm) subcutaneous fat tissue. The physician
may hold pressure-reading device 70 against the patient's skin near the location of
the pressure measuring device 64 and observe the pressure reading on a display on
the control box 90. The housing including the pressure measuring device 64 can be
palpably located near a surface of the patient's skin, typically at or near an expected
location of the housing's body which can substantially maintain its location if and/or
when the profile of the housing lowers. The pressure reading device 70 can also be
removably attached to the patient, such as during a prolonged examination, using straps,
adhesives, and other well-known methods. The pressure reading device 70 can operate
through conventional cloth or paper surgical drapes, and can also include a disposal
cover (not shown) that may be replaced for each patient.
[0048] FIGS. 5 16 illustrate embodiments of housings that each include a body and a base.
Some embodiments also include at least one coupling element extending between the
body and the base. The housing, the base, and the body are similar to those described
with reference to similarly named elements of FIGS. 1A 4. Furthermore, the embodiments
in FIGS. 5 16 can include variations as described herein. Generally, the housing body
seats an implantable restriction system element, e.g., a fill port or a sensor, that
can be in fluid communication with one or more other elements included in the implantable
restriction system. The housing base couples the housing to the patient using any
fixation technique, e.g., sutures. The housing's body and base are movably coupled
to one another to allow adjustment of the housing's height up and/or down from a first
height to a second height that can be less than or greater than the first height depending
on whether the housing's height is being, respectively, decreased or increased. The
housing can have any number of additional heights between the first and second heights,
with a height being less than the preceding height(s) if the housing's height is being
decreased or more than the preceding height(s) if the housing's height is being increased.
A housing height can be more than one or more preceding heights if the housing profile
is being increased to, for example, adjust a patient's treatment regime. Maximum and
minimum heights of the housing can vary, but in some embodiments, the housing's height
ranges from about 1 cm to 3 cm.
[0049] Referring first to FIGS. 5 9, embodiments of a housing 100 each include a housing
body 102, a housing base 104, and at least one coupling element extending between
the body 102 and the base 104 that can be operable to alter a distance between the
body 102 and the base 104 to thereby adjust the height of the housing 100. The coupling
element is substantially disposed in the housing 100, e.g., in an internal cavity
106 defined by an interior surface 108 of the body 102 and an interior surface 110
of the base 104. The surfaces 108, 110 can define the internal cavity 106 to have
a fluid tight seal. The body's interior surface 108 and the base's interior surface
110 are shaped to slidably couple the body 102 and the base 104 together. The internal
cavity 106 extends around a perimeter the housing 100, which in these embodiments
is a circular circumference around the substantially cylindrical housing 100. The
internal cavity 106 can, in other embodiments, extend around only a portion of the
housing's perimeter and/or be divided into two or more individual internal cavities.
The body's interior surface 108 and the base's posterior surface 110 also define a
second internal cavity 112, in a central region of the housing 100. The internal cavities
106, 112 can be in fluid communication in some embodiments. Additionally, the internal
cavities 106, 112 can each have any shape and size. The height of the housing 100
can be adjusted through manipulation of the coupling element in the internal cavity
106 from outside the patient, e.g., as controlled by a physician. The housing 100
can couple to a patient at one or more locations on an outer surface 136 in a proximal
portion 138 of the housing base 104.
[0050] As illustrated in FIG. 5, one example of a coupling element includes a fluid 114
(e.g., a liquid such as saline or a gas such as carbon dioxide) disposed in the internal
cavity 106 between the body 102 and the base 104. The fluid 114 typically includes
any type of biocompatible material appropriate for use in a body to minimize patient
harm in the uncommon occurrence of housing rupture or other unintended fluid leakage.
The internal cavity 106, and hence any fluid it contains, can be accessed through
a housing membrane 116 on the housing body 102. The housing membrane 116 can be fluid
sealed using a bellows. The fluid 114 is typically initially introduced to the internal
cavity 106 through the housing membrane 116 after the housing 100 has been implanted,
although the internal cavity 106 can contain the fluid 114 before the housing's implantation.
The housing base 104 can also have a housing membrane providing access to the internal
cavity 106 in addition to or instead of the housing membrane 116 on the housing body
102. The housing membrane 116 is similar to the port's needle penetrable septum 34
of FIG. 3, allowing a needle 118, such as Huber needle, to puncture the housing membrane
116 and self seal when the needle 118 is withdrawn. When a fluid volume changes in
the internal cavity 106, such as by drawing fluid through the needle 118, a height
between the housing body 102 and the housing base 104 can decrease. In other words,
when at least a portion of the fluid 114 is evacuated from the internal cavity 106,
the housing's profile can lower as the base's interior surface 110 moves closer to
the body's interior surface 108 and occupies some of the internal cavity 106 space
previously occupied by the fluid 114.
[0051] Enough of the fluid 104 can be removed from the internal cavity 106 such that the
body 102 and the base 104 can lock together via a locking mechanism when the base
102 and the body 104 are in sufficient proximity of each other, e.g., when the coupling
element draws the base 102 and the body 104 together and/or the body 102 and the base
104 are physically compressed together. Examples of locking mechanisms include a snap
locking mechanism (as shown in FIG. 5) and a compression press fit. The body's interior
surface 108 in this embodiment includes at least one protrusion 120 that can lock
in at least one corresponding depression 122 in the base's inferior surface 110. In
this embodiment, the protrusion 120 and the depression 122 extend around the housing's
perimeter, although the housing 100 can include any number of corresponding protrusions
and depressions anywhere in the interior surfaces 108, 110, including in the second
internal cavity 112.
[0052] The embodiment of the housing 100 shown in FIG. 5 is a port housing (e.g., the port
housing 30) having a septum 124 and a reservoir 126 seated in the housing body 102
(e.g., in a proximal opening of the housing 100). The housing body 102 also includes
a barb fitted connection member 128 (e.g., the catheter tube connection member 36)
that is in fluid communication with the reservoir 126 and that is configured to couple
to a catheter 130 (e.g., the catheter 50). The connection member 128 can be coupled
to the housing body 102 at any location. Moreover, in some embodiments discussed further
below, the housing base 104 can have a slotted or otherwise cut out area in its perimeter
(in which case the housing base 104 may not be completely circumferential) to allow
the connection member 128 and/or the catheter 130 to extend from the housing body
102.
[0053] The housing 100 illustrated in FIG. 6 is similar to the embodiment of FIG. 5 except
that the housing 100 in FIG. 6 is a sensor housing (e.g., the sensor housing 60) having
a sensor 132 (e.g., the pressure measuring device 64) seated in the housing body 102.
Although not shown, the housing body 102 and/or the housing base 104 can include one
or more connection members (e.g., the connection member 128) to accommodate catheter
connections for the sensor 132 (e.g., the inlet 62a and the outlet 62b).
[0054] In some embodiments, the coupling element between the body 102 and the base 104 can
include a compliant mechanism that is compressible to decrease the distance between
the housing body 102 and the housing base 104. One example of a compliant mechanism
is a spring 134, as illustrated in FIG. 7. The spring 134 can include any flexible
elastic object having any shape. For example, the spring 134 can include a coil or
helical spring having a cylindrical shape as shown in FIG. 7, although the coil spring
can have other shapes, such as conical or dual conical, and have individual coils
of any shape, such as elliptical or rectangular. Other examples of the spring 134
include an elastic band/thread/cord, a bellows (see FIGS. 11 12, discussed below),
a volute spring (see FIGS. 13 14, discussed below), and other similar types of flexible
elastic objects. The spring 134 can also have a variety of sizes, and different springs
used with the housing 100 can have different sizes (and shapes). The spring 134 can
be made from any type of and any combination of material, typically a biocompatible
material appropriate for use in a body, such as a polymer, biocompatible metal, and
other similar types of material.
[0055] As shown in FIG. 7, the spring 134 is disposed in the internal cavity 106 and extends
between the interior surface 108 of the body 102 and the interior surface 110 of the
base 104. Alternatively or in addition, the spring 134 can extend between the interior
surface 108 of the body 102 and the interior surface 110 of the base 104 in the second
internal cavity 112. The spring 134 as shown includes two individual springs located
on opposite sides of the cylindrical housing 100, but any number of springs can extend
between the body 102 and the base 104. For example, one or more springs can be disposed
at intervals (which can be equal or variable between any two or more springs) inside
the internal cavity 106 around the perimeter of the housing 100. As another example,
the spring 134 can be disposed as illustrated in FIG. 7 with an additional spring
centrally located in the second external cavity 112 extending between the interior
surfaces 108, 110.
[0056] The spring 134 has at least two successive positions: expanded and collapsed. The
spring 134 typically begins in the expanded position in which it is biased to maintain
a substantially constant distance between the body 102 and the base 104. One or more
compressions can be applied to the spring 134 to compress the spring 134 to the collapsed
position, thereby decreasing the height of the housing 100 to its lowest profile.
The spring 134 can have one or more successive positions between the expanded and
collapsed positions such that one or more compressions applied to the spring 134 can
align and maintain the spring 134 in partially collapsed position(s) between its expanded
and collapsed positions, thereby allowing the housing 100 to lower in height with
each successive position.
[0057] Compressions can be applied to the housing 100 in a variety of ways, such as by applying
pressure to the body 102 and/or the base 104 from inside and/or outside the patient's
body. The housing 100 is typically compressed by a physician to help prevent injury
to the patient and to ensure continued proper functioning of the housing 100.
[0058] The housing 100 can include a safety mechanism that must be changed from a locked
to an unlocked position before pressure applied to the body 102 and/or the base 104
can change the profile of the housing 100. Examples of safety mechanisms include a
mechanical or electrical lock included on or in the housing 100 that a physician can
physically manipulate through an incision in the patient or non invasively manipulate
using an electronic device placed against the patient's skin near the location of
the housing 100.
[0059] When the spring 134 has been compressed to a degree such that the interior surface
108 of the body 102 and the interior surface 110 of the base 104 are in sufficient
proximity of each other, a locking mechanism, such as corresponding protrusions 137
and depressions 139, can engage and lock the body 102 and the base 104 together as
described above. In some embodiments, one or more compressions of the spring 134 can
cause the spring 134 to break, allowing the housing 100 to decrease in height. The
broken spring can remain inside the internal cavity 106 with ends still attached to
the interior surface 108 of the body 102 and the interior surface 110 of the base
104. With the spring 134 broken, the body 102 and the base 104 can be compressed together
and lock via a locking mechanism.
[0060] The housing 100 shown in FIG. 7 also includes the connection member 128 coupled to
the housing body 102. In this embodiment, the catheter 130 extends through the housing
body 102, the second internal cavity 112, and the housing base 104, exiting the housing
100 from the proximal portion 138 of the housing base 104 rather than from the housing
body 102. Such a configuration can allow the catheter 130 to extend outside the housing
100 for a shorter distance, thereby reducing chances of catheter snagging, tangling,
and rupture, because the housing body 102 and the housing base 104 can be separated
by thick subcutaneous fat tissue, with the housing base 104 nearer the next destination
of the catheter 130 (e.g., a sensor housing) than the housing body 102.
[0061] Another example of a coupling element is any element that can be movable between
a first position, in which the housing 100 has a first height, and a second, successive
position, in which the housing 100 has a second height that is different from the
first height. The coupling element can also be movable between one or more successive
positions before and/or after moving from the first to the second position such that
the housing's height lowers with each successive position. One example of such a coupling
element is a tab 140, shown in FIG. 8. The tab 140 can include at least one flexible
tab extending between the body 102 and the base 104 that can maintain the housing
100 in at least one of the successive positions. The tab 140 can have any size and
any shape. For example, the tab 140 can include a rod, a flap, and other similar types
of elliptical, rectangular, linear, or otherwise shaped elements having two or three
dimensions. The tab 140 can be made from any type of and any combination of material,
typically a biocompatible material appropriate for use in a body.
[0062] The tab 140 is disposed in the internal cavity 106 and extends between the interior
surface 108 of the body 102 and the interior surface 110 of the base 104. Two tabs
140 are illustrated in FIG. 8 on opposite sides of the housing 100, but the housing
100 can include any number of tabs in any configuration.
[0063] In this embodiment, the tab 140 includes a tab body portion 142 and an L bracket
144. The housing 100 can include any number of tab body portions 142 and any number
of L brackets 144, where one L bracket 144 can be associated with one or more tab
body portions 142. The tab body portion 142 is coupled to the interior surface 108
of the housing body 102, which it extends from in a substantially perpendicular direction,
although it can extend in any direction that allows it to engage the L bracket 144.
The L bracket 144 extends from the interior surface 110 of the housing base 104 in
a substantially perpendicular direction and angles toward the interior surface 108
of the housing body 102 to allow engagement with the tab body portion 142 in a lock
step fashion.
[0064] The tab 140 has at least two positions. The tab 140 is illustrated in a first position,
with the L bracket 144 engaging a distal most tab body portion 142. The housing base
104 can be compressed toward the housing body 102, as described above, thereby disengaging
the tab body portion 142 and the L bracket 144 and putting the tab 140 into a second
position that provides a lower housing profile than the tab 140 in the first position.
When the housing 100 is compressed, the interior surfaces 108, 110 approach each other
and the L bracket 144 can engage another tab body portion 142 (if the body 102 includes
more than one tab body portion 142). The tab body portion 142 is typically made from
a flexible material that can flex to disengage from the L bracket 144, and the L bracket
144 can also or instead be made from a flexible material to help engage/disengage
the tab portion 142. If there are no tab body portions for the L bracket 144 to engage
as the housing body 102 and housing base 104 are compressed together, the housing
body 102 and the housing base 104 can compress together to engage a locking mechanism,
also as described above.
[0065] In this embodiment, the locking mechanism includes the tab 140, more specifically
the tab body portion 142, and a slot 146 formed in, cut out from, or otherwise present
in the outer surface 136 of the housing base 104 (or on the interior surface 110 of
the housing base 104, depending on the position of the tab body portion 142 on the
housing body 102). The tab body portion 142 can engage the slot 136, thereby locking
the housing body 102 and the housing base 104. The slot 146 is typically in the proximal
portion 138 of the housing base 104. If the housing 100 includes two or more tabs
140, any number of the tabs 140 can have a corresponding slot 146, although one slot
146 to engage one tab 140 can be enough to lock the housing 100.
[0066] A movable tab 148, shown in FIG. 9, is another example of a coupling element that
can be movable between a first position, in which the housing 100 has a first height,
and a second, successive position, in which the housing 100 has a second height that
is different from the first height, with any number of successive positions before
and/or after the first and second positions. The movable tab 148 can be a tab as described
above with respect to FIG. 8 having any size, any shape, any number and configuration
on the housing 100, and any material composition. Similar to the tab body portion
142, the movable tab 148 can engage one or more slots 150, similar to the slot 146
of FIG. 8. Unlike the tab body portion 142, however, the movable tab 148 is coupled
to a depressible element 152 at least partially extending outside the housing body
102 that can be depressed to move the movable tab 148 from the first position to the
second position (and any other possible successive positions). In other words, the
depressible element 152 can be depressed to compress the housing body 102 and the
housing base 104 together by moving the movable tab 148 such that the movable tab
148 can engage one or more slots 150.
[0067] The depressible element 152 can have a variety of configurations that allow it to
move the movable tab 148. In the illustrated embodiment, the depressible element 152
includes a button formed on the housing body 102, although the button can be formed
anywhere on the housing 100. The housing 100 typically includes one depressible element
152 as shown, although the housing 100 can include any number of depressible elements
152. The depressible element 152 is at least partially accessible outside the housing
100 whether or not it extends beyond the housing body's posterior surface 164. If
the depressible element 152 does not extend beyond the housing body's posterior surface
164, which it may not to reduce chances of accidental depression of the depressible
element 152, then an instrument such as a needle can be used to depress the depressible
element 152.
[0068] The depressible element 152 can be coupled to the movable tab 148 via an elongate
shaft 154. The elongate shaft 154 can extend from the depressible element 152 and
into a bore 156 formed in the housing body 102. The movable tab 148 can couple to
the elongate shaft 154 inside the bore 156 and extend into the internal cavity 106
where it can engage the slot 150. In this embodiment, the elongate shaft 154 directly
engages the movable tab 148, but in some embodiments, one or more additional elements
can be included between the elongate shaft 154 and the movable tab 148. Moreover,
one or more additional movable tabs can be coupled to the elongate shaft 154 and move
similar to the movable tab when the depressible element 152 is depressed. A spring
158 (which can have any configuration, as described above for the spring 134 of FIG.
7) disposed in the bore 156 and coupled to the movable tab 148 can provide tension
sufficient hold the movable tab 148 in position within the internal cavity 106 and
the bore 156 when the depressible element 152 is in an uncompressed position. The
depressible element 152 can be removably or fixedly coupled to the elongate shaft
154.
[0069] Depressing the depressible element 152 can also depress the elongate shaft 154. The
elongate shaft 154, when depressed, can slidably move the movable tab 148 along one
or more bearings 160 (or other slidable element) in a direction away from the internal
cavity 106 and toward the bore 156 such that the spring 158 compresses. Although five
bearings 160 are shown, any number of bearings 160 can be disposed in the bore 156.
Fully depressing the depressible element 152 can provide enough slidable motion of
the movable tab 148 to disengage the movable tab 148 from the slot 150, although in
other embodiments a partial depression of the depressible element 152 can disengage
the movable tab 148 from the slot 150. The movable tab 148 is typically made from
a rigid enough material so it cannot disengage from the slot 150, e.g., if the housing
100 is physically compressed, without depression of the depressible element 152 allowing
it to move out of the slot 150. With the movable tab 148 disengaged from the slot
150 and in another position, the housing body 102 and the housing base 104 can be
compressed together as described above. The depressible element 152 can be released
from depression, thereby releasing tension from the spring 158 and allowing the movable
tab 148 to slide along the bearings 160 toward the internal cavity 106. When one of
the slots 150 becomes properly aligned with the movable tab 148, the movable tab 148
can engage the slot 150 and be in another position that provides another housing profile.
Proper slot 150 to tab 148 alignment can occur either before or after the depressible
element 152 has been released because the outer surface 136 of the housing base 104
can prevent the movable tab 148 from moving into the internal cavity 106 until one
of the slots 150 is properly aligned with the movable tab 148.
[0070] The housing 100 can include one or more coupling elements in addition to the movable
tab 148. The additional coupling element(s) can have any configuration, although typically
at least one additional coupling element is located on an opposite side of the housing
100 from the movable tab 148 to help maintain a level housing profile. For example,
as shown in FIG. 9, the housing 100 can include a tab 162 as described above with
reference to FIG. 8, that can engage one or more slots 150 as the housing body 102
and the housing base 104 are compressed together. The number of available slots 150
is typically the same for the movable tab 148 and for any other tabs coupled to the
housing body 102 (e.g., the tab 162) to help maintain a level housing profile.
[0071] FIG. 10 illustrates another embodiment of a housing 200 at least partially formed
from a bioabsorbable material operable to adjust the height of the housing 200 over
time. The bioabsorbable material can degrade within the patient, thereby lowering
the profile of the housing 200 in proportion to the degradation. The housing 200 includes
a body 202 formed from a biocompatible material appropriate for use in a body and
a base 204 formed from a bioabsorbable material. The bioabsorbable material can degrade
uniformly (e.g., bulk hydrolysis) or proportionally to its surface area. Examples
of bioabsorbable materials include bioabsorbable polymers such as polylactides (PLA),
polyglycolides (PGA), poly(lactide co glycolides) (PLGA), polyanhydrides, polyorthoesters,
and other similar types of materials that can break down inside a patient and be absorbed
or otherwise safely processed by the patient's body.
[0072] Any amount of bioabsorbable material can be used to form the base 204 having any
height H. The height H generally corresponds to a desired distance between the fascia
where the housing 200 is fixed to the patient and the implantable restriction element
seated in the body 102, which in this embodiment is a port including a reservoir 206
and a septum 208. As the bioabsorbable material of the base 204 is reabsorbed, the
height H of the base 204 can decrease, thereby moving the housing 200 from a maximum
height to a minimum height, with any number of successive heights in between. The
bioabsorbable material can degrade to allow different heights over any period of time,
e.g., two to three years after implantation.
[0073] Other embodiments of a housing 300, illustrated in various configurations in FIGS.
11 16, include a housing body 302 a housing base 304, and at least one coupling element
306 extending between the body 302 and the base 304 that can be operable to alter
a distance between the body 302 and the base 304 to adjust the height of the housing
300. A locking mechanism can engage and lock the housing body 302 and the housing
base 304 together as described above. The coupling element 306 in these embodiments
need not be substantially disposed in the housing body 302 or the housing base 304.
Rather, the coupling element 306 can couple outside surfaces of the housing body 302
and the housing base 304, such as at their respective interior surfaces 308, 310.
A portion of the coupling element 306 can extend into the housing body 302 and/or
the housing base 304 when the housing 300 has any height, but typically, at least
when the housing 300 is at its maximum height, substantially all of the coupling element
306 is disposed outside the housing body 302 and the housing base 304. Fat tissue
can be compacted around the coupling element 306 when it is implanted to help maintain
the coupling element's position and to help allow lost weight to alter the coupling
element's position. Although not shown in FIGS. 11 16, the coupling element 306 can
include a protective sheath disposed around at least a portion of its exterior surface,
similar to a bellows. The coupling element 306 (and its sheath, if present) can be
made from any biocompatible material appropriate for use in a body.
[0074] The housing 300 can also include a connection member 312 (e.g., the catheter tube
connection member 36) that can couple to the housing body 302 and to a catheter 314
(e.g., the catheter 50). The connection member 312 is shown in a lateral configuration
extending horizontally from the housing body 302 in FIGS. 13 14, but the connection
member 312 can have other configurations on the housing body 102. For example, as
illustrated in FIGS. 11 12, the connection member 312 can extend vertically from the
interior surface 308 of the housing body 302.
[0075] One embodiment of the coupling element 306 includes a compliant mechanism, e.g.,
a collapsible structure, that has an expanded position, as illustrated in FIG. 11
where the housing 300 has a height H1, and a collapsed position, as shown in FIG.
12 where the housing 300 has a height H2 that is less than the height H1. Another
embodiment of the coupling element 306 includes a compliant mechanism illustrated
in FIGS. 13 and 14 that includes a collapsible structure similar to that shown in
FIGS. 11 and 12. (H1 and H2 need not represent the same heights in FIGS. 11 12 and
FIGS. 13 14.) The coupling element 306 in FIGS. 11 14, described further below, can
include any flexible object having any configuration, as described above regarding
the spring 134 of FIG. 7. As the patient loses weight, the coupling element 306 can
collapse as fat tissue supporting it dissipates. The coupling element 306 can also
or instead be manually compressed, such as described above regarding the spring 134.
In positions where the housing 300 has a height less than its maximum height, some
or all of the coupling element 306 can collapse into the housing base 302, the housing
body 304, and/or itself. For example, from the position shown in FIG. 13, the coupling
element 306 has nested into itself to have the position shown in FIG. 14.
[0076] In another embodiment of the housing 300, illustrated in FIG. 15, the coupling element
306 includes a compliant mechanism such as a spring 316 (e.g., a spring as described
above regarding the spring 134 of FIG. 7) that is compressible to decrease the distance
between the housing body 302 and the housing base 304. The coupling element 306 also
includes a rack 318 having a plurality of teeth 320. The rack 318 can be coupled to
the spring 316 via a pawl 322 that can engage the teeth 320 for maintaining the housing
300 at a selected height.
[0077] The rack 318 can have any configuration that allows for height adjustment of the
housing 300. In the illustrated embodiment, the rack 318 extends between the interior
surface 308 of the housing body 302 and the interior surface 310 of the housing base
304 as a substantially rectangular box shaped structure, although the rack 318 can
have any two dimensional or three dimensional shape. The rack 318 can also have any
size. The rack 318 can also include a support, such as a spring 324 (e.g., a spring
as described above regarding the spring 134 of FIG. 7), to help provide stability
between the housing body 302 and the housing base 304. The rack 318 can be made of
any type of and any combination of rigid and/or flexible material, typically a biocompatible
material appropriate for use in a body.
[0078] If the rack 318 is made from a flexible material, the rack 318 can be redirected
through the housing base 304 as the housing's height changes, as illustrated with
dotted lines inside the housing base 304 and with solid lines outside a left surface
of the housing base 304. The rack 318 can, however, be redirected to extend outside
any surface of the housing base 304. The rack 318 can also be disposed within the
housing base 304 before and/or after redirection. For example, the housing 300 may
not be sufficiently collapsed to include a redirected rack portion inside the housing
base 304. As another example, for any given height of the housing 300, the housing
base 304 can be of sufficient size to contain the rack 318 and/or the rack 318 can
be sufficiently flexible to be redirected within the housing base 304.
[0079] The teeth 320 coupled to the rack 318 can also have any shape and size and be composed
of any, typically biocompatible, material. The teeth 320 can be oriented on the rack
318 to, along with the pawl 322, allow motion of the rack 318 in a desired direction,
e.g., a direction to decrease the housing's height. The pawl 322 can include any protrusion
that can engage the teeth 320 to maintain the housing 300 at a selected height. The
pawl 322 can rest against a surface of any one of the teeth 320 to maintain housing
height and be movable between one or more of the other teeth 320 to change the housing's
profile. The spring 316 coupling the pawl 322 to the patient, along with the shapes
of the teeth 320 and the pawl 322, can provide bias against motion of the rack 318
opposite to the desired direction. Although the spring 316 and the rack 318 are shown
oriented substantially perpendicular to each other in a resting, non motion position,
the spring 324 and the rack 318 can be oriented with respect to each other in any
direction that can allow the pawl 322 to engage the teeth 320 and the housing 300
to change height.
[0080] FIG. 16 illustrates still another embodiment of the housing 300 where the coupling
element includes a retractable cord 306 coupling the housing body 302 and the housing
base 304 at their interior surfaces 308, 310, although the retractable cord 306 can
be coupled to any surfaces of the housing body 302 and the housing base 304. The retractable
cord 306 can include any flexible elastic cord (e.g., string, thread, band, fiber,
etc.) having any shape and any length. The retractable cord 306 can be made from any
type of and any combination of material, typically a biocompatible material appropriate
for use in a body. The patient's fat or tissue can provide a force to maintain separation
of the housing base 304 and the housing body 302, as shown by directional arrows in
FIG. 16. The force can maintain the retractable cord 306 in a particular position
(e.g., maintain the retractable cord 306 at a certain length). As the patient loses
weight, the force on the retractable cord 306 can change, thereby allowing the retractable
cord 306 to retract into the housing body 304 and allow the housing 300 to change
height.
[0081] The retractable cord 306 can be disposed inside the housing base 304 in variety of
ways. For example, as shown in this embodiment, the retractable cord 306 can coil
around a reel 326 disposed inside the housing base 304 and coupled to one end of the
retractable cord 306. The reel 326 in this embodiment is substantially elliptical
and made from a rigid, biocompatible material, but the reel 326 can have any shape,
size, and composition. The reel 326 can also have any orientation within the housing
base 304 where the retractable cord 306 extends outside the housing base 304 in a
direction substantially parallel to the reel's plane. As another example, in other
embodiments, the retractable cord 306 can accordion fold inside the housing base 304.
[0082] A person skilled in the art will appreciate that the present invention has application
in conventional endoscopic and open surgical instrumentation as well application in
robotic assisted surgery.
[0083] The devices disclosed herein can be designed to be disposed of after a single use,
or they can be designed to be used multiple times. In either case, however, the device
can be reconditioned for reuse after at least one use. Reconditioning can include
any combination of the steps of disassembly of the device, followed by cleaning or
replacement of particular pieces, and subsequent reassembly. In particular, the device
can be disassembled, and any number of the particular pieces or parts of the device
can be selectively replaced or removed in any combination. Upon cleaning and/or replacement
of particular parts, the device can be reassembled for subsequent use either at a
reconditioning facility, or by a surgical team immediately prior to a surgical procedure.
Those skilled in the art will appreciate that reconditioning of a device can utilize
a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use
of such techniques, and the resulting reconditioned device, are all within the scope
of the present application.
[0084] Preferably, the invention described herein will be processed before surgery. First,
a new or used instrument is obtained and if necessary cleaned. The instrument can
then be sterilized. In one sterilization technique, the instrument is placed in a
closed and sealed container, such as a plastic or TYVEK bag. The container and instrument
are then placed in a field of radiation that can penetrate the container, such as
gamma radiation, x-rays, or high-energy electrons. The radiation kills bacteria on
the instrument and in the container. The sterilized instrument can then be stored
in the sterile container. The sealed container keeps the instrument sterile until
it is opened in the medical facility.
[0085] It is preferred that device is sterilized. This can be done by any number of ways
known to those skilled in the art including beta or gamma radiation, ethylene oxide,
steam.
[0086] One skilled in the art will appreciate further features and advantages of the invention
based on the above-described embodiments. Accordingly, the invention is not to be
limited by what has been particularly shown and described, except as indicated by
the appended claims. All publications and references cited herein are expressly incorporated
herein by reference in their entirety.
[0087] The following is a non-exhaustive list of embodiments of the invention that may be
claimed in this application or in subsequently filed divisional applications:
- 1. A restriction system for forming a restriction in a patient, comprising:
an implantable restriction device configured to form a restriction in a patient; and
an implantable housing coupled to the implantable restriction device and having a
height that is adjustable.
- 2. The system of embodiment 1, wherein the housing is in fluid communication with
the implantable restriction device.
- 3. The system of embodiment 2, wherein the housing includes a fill port configured
to receive fluid from a fluid source external to the patient for delivering fluid
to the implantable restriction device.
- 4. The system of any preceding embodiment, wherein the housing includes a pressure
sensor configured to sense a pressure of fluid within the implantable restriction
device and configured to communicate pressure data to an external monitor.
- 5. The system of any preceding embodiment, further comprising a coupling element extending
between a base of the housing and a body of the housing and operable to alter a distance
between the base and the body to thereby adjust the height of the housing.
- 6. The system of embodiment 5, wherein the coupling element comprises a fluid filled
chamber, and wherein a change of fluid volume within the chamber alters the distance
between the base and the body.
- 7. The system of embodiment 5, wherein the coupling element comprises a compliant
mechanism that is compressible to decrease the distance between the base and the body.
- 8. The system of embodiment 7, wherein the compliant mechanism comprises a spring.
- 9. The system of embodiment 7, wherein the coupling element further comprises a rack
coupled to the compliant mechanism and including a plurality of teeth, and a pawl
configured to engage the rack for maintaining the housing at a selected height.
- 10. The system of embodiment 5, wherein the coupling element comprises a collapsible
structure.
- 11. The system of embodiment 5, wherein the coupling element comprises a retractable
cord.
- 12. The system of embodiment 5, wherein the coupling element is movable between at
least two successive positions in which the housing has a height that lowers with
each successive position of the coupling element.
- 13. The system of embodiment 12, wherein the coupling element comprises at least one
flexible tab extending between the base and the body and adapted to maintain the housing
in at least one of the successive positions.
- 14. The system of embodiment 12, further comprising a depressible element adapted
to be depressed to move the coupling element between at least two successive positions.
- 15. The system of embodiment 14, wherein the depressible element comprises a button
formed on one of the body and the base.
- 16. The system of embodiment 1, wherein the housing is at least partially formed from
a bioabsorbable material operable to adjust the height of the housing over time.
- 17. The system of embodiment 16, wherein the bioabsorbable material is selected from
the group consisting of polylactide, polyglycolide, poly(lactide co glycolide), polyanhydride,
and polyorthoester.
- 18. A restriction system for forming a restriction in a patient, comprising:
an implantable restriction device configured to form a restriction in a patient; and
an implantable housing coupled to the implantable restriction device and having a
body and a base that are movably coupled to one another to allow a height of the housing
to be adjusted.
- 19. The system of embodiment 18, wherein the base is formed from a bioabsorbable material
operable to adjust the height of the housing over time.
- 20. The system of embodiment 18 or 19, further comprising a coupling element extending
between the base and the body and operable to alter a distance between the base and
the body to thereby adjust the height of the housing.
- 21. The system of embodiment 20, wherein the coupling element is movable between at
least two successive positions in which the housing has a height that lowers with
each successive position of the coupling element.
- 22. A method of forming a restriction in a patient, comprising:
implanting a restriction device in a patient to form a restriction; and
adjusting a height of a housing coupled to the restriction device and implanted within
tissue to lower a profile of the housing.
- 23. The method of embodiment 22, wherein adjusting a height of the housing comprises
adjusting a coupling element extending between a base of the housing and a body of
the housing.
- 24. The method of embodiment 22, wherein adjusting a height of the housing comprises
allowing the housing to biomedically degrade within the patient.